Sun Pharmaceutical Industries Ltd. announced that US FDA has granted final approval for the company's Abbreviated New Drug Application (ANDA) to market its generic version of Wyeth's Protonix, pantoprazole tablets.

These generic pantoprazole tablets are AB-rated equivalent of Wyeth's Protonix Delayed Release tablets and include two strengths: 20 mg (base) and 40 mg (base). These strengths of Protonix have annual sales of approximately USD 2.3 billion in the US, a company press release stated.

Sun Pharma, being one of the first-to-file an ANDA for generic Protonix with a para IV certification, shares a 180-day marketing exclusivity.

Pantoprazole is indicated for short term treatment of erosive esophagitis associated with GERD, maintenance of healing of erosive esophagitis and for treatment of hypersecretory conditions.

The company is currently evaluating its launch options, the release added.